Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002 - The importance of reporting suspected reactions
Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002 - The importance of reporting suspected reactions
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DOI：
10.1001/archinte.165.12.1363
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发表时间：
2005-06-27
影响因子：
--
通讯作者：
Swartz, L
中科院分区：
文献类型：
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作者：
Wysowski, DK;Swartz, L
背景资料：不良事件报告系统是主要的监测数据库，由食品和药物管理局用于识别上市后的药物safetyproblem.Methods：我们分析了所有报告的可疑药物不良反应提交给食品和药物管理局从成立以来的不良事件报告系统数据库在1969年至2002年12月。我们记录的药物撤回和限制分销计划的基础上safety concerns.Results：在33年期间，从1969年开始，通过2002年的药物不良事件报告时，约230万例报告的不良事件的累积数量约6000上市药物进入数据库。大多数报告为女性患者。在此期间，已识别出许多药物反应，并将其作为黑框警告、警告、注意事项、禁忌症和不良反应添加到产品标签中。超过75种药物/药品因安全问题被从市场上撤下。此外，还有11种药品对处方有特殊要求或有限售计划。撤回或限制的药物代表一小部分（约1%）的上市drugs.Conclusions：美国食品和药物管理局的不良事件报告系统是主要的监测数据库用于识别上市药物的安全性问题。尽管存在报告不足、差异报告和质量参差不齐的局限性，但提交的报告通常允许识别添加到产品标签信息中的严重不良事件。在极少数情况下，需要制定额外的法规，包括市场移除。我们鼓励医生、药剂师、其他医疗保健专业人员和患者继续向制造商和食品药品监督管理局报告严重的疑似和已知药物不良反应。
Background: The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems.Methods: We analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002. We documented drug withdrawals and restricted distribution programs based on safety concerns.Results: During the 33-year period from 1969 when adverse drug event reporting was initiated through 2002, about 2.3 million case reports of adverse events for the cumulative number of approximately 6000 marketed drugs were entered in the database. Most reports were for female patients. During this period, numerous drug reactions have been identified and added to the product labeling as boxed warnings, warnings, precautions, contraindications, and adverse reactions. More than 75 drugs/drug products have been removed from the market due to safety problems. In addition, 11 drugs have special requirements for prescriptions or have restricted distribution programs. Drugs withdrawn or restricted represent a small proportion (about 1%) of marketed drugs.Conclusions: The Food and Drug Administration's Adverse Event Reporting System is the primary surveillance database used for the identification of safety problems of marketed drugs. Despite the limitations of underreporting, differential reporting, and uneven quality, submitted reports often allow the identification of serious adverse events that are added to the product labeling information. In rare instances, additional regulations, up to and including market removal, have been required. We encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adverse drug reactions to manufacturers and the Food and Drug Administration.